Corstasis Therapeutics Announces FDA Approval of ENBUMYST™ – First Nasal Spray Loop Diuretic for Edema
Corstasis Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ENBUMYST™ (bumetanide nasal spray) for the treatment of edema associated with congestive heart failure (CHF), liver disease, and kidney disease (including nephrotic syndrome) in adults.
This approval marks a first-in-class innovation — ENBUMYST is the first and only intranasal loop diuretic available in the U.S., offering patients a self-administered alternative between oral and intravenous diuretics.
Why It Matters
- Edema & fluid overload remain leading causes of hospitalization for CHF, cirrhosis, and chronic kidney disease.
- Oral diuretics can be unreliable due to poor absorption; IV therapy requires hospital settings.
- ENBUMYST bridges this gap — providing rapid absorption and a predictable diuretic response comparable to IV therapy, but in a convenient nasal spray.
“The FDA approval of ENBUMYST represents a meaningful advancement in the treatment of edema for patients and providers,” said Ben Esque, CEO of Corstasis Therapeutics.
Market Opportunity
- An estimated 6.7 million Americans live with heart failure.
- Fluid overload drives >1 million hospitalizations annually, with billions spent in healthcare costs.
- ENBUMYST, expected to launch in Q4 2025, is set to address this multi-billion-dollar market by enabling earlier outpatient care and reducing costly readmissions.
Safety Information
ENBUMYST is contraindicated in patients with:
- Anuria
- Hepatic coma
- Known hypersensitivity to bumetanide
⚠️ Risks include fluid and electrolyte imbalance, dehydration, and metabolic abnormalities. The most common adverse reactions: hypovolemia, headache, dizziness, hypotension, nausea, muscle cramps, and encephalopathy (in liver disease patients).
For full prescribing details, see Corstasis Therapeutics.
About Corstasis Therapeutics
Corstasis is a biopharmaceutical company focused on innovative outpatient therapies for cardiovascular and renal disease. Its pipeline includes novel formulations such as subcutaneous diuretic products, aiming to improve patient outcomes, reduce hospitalizations, and lower overall healthcare costs.
👉 ENBUMYST offers patients and providers a new tool — practical, fast, and hospital-free.
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